(396 days)
The Pronto Pump Tube Set is a part of the Pronto Pump System. This tube set provides peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution in healthcare environments. The Pronto Pump Tube set provides the fluid path way and pumping mechanism for the pump system.
The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
The ProntoPump Sterile Tube Sets are fluid transfer tube sets used in conjunction with the ProntoPump pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
The ProntoPump sterile tube set is a single channel tube set for use with the ProntoPump pharmacy pump. It consists of clear plastic tubing connected to a silicone tube that functions as a peristaltic pumping chamber. Peristaltic pumps function by a roller compressing the pump tubing and rolling along the length of the tube, squeezing the fluid inside the tube from one end to the other. It has a plastic cassette that holds the pumping chamber in place for insertion into the ProntoPump, which provides the rollers that the force the fluid to move. The proximal and distal ends of the PVC tubing have connectors for various devices and containers. Using the ProntoPump, the tube set is used to deliver specified volumes of liquid into a final dosing container in hospital pharmacies or compounding pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
The cassette is non-fluid-contact and helps hold the tubing in place for loading. It has a machine-readable barcode that can be read by the pharmacy pump. The barcode includes information about the particular tube set item number, lot number, and expiration date, which is used by pharmacy pump to facilitate set up of the tubing.
The tube set is intended to be used by trained healthcare personnel, and is not intended to be used for direct patient contact. Tube sets are packaged individually in a peel pouch and sterilized by radiation.
The provided text describes the regulatory clearance for the "ProntoPump Sterile Tube Set" (K200893) and its substantial equivalence to a predicate device (K062909). However, it does not explicitly state "acceptance criteria" for performance in a table format with specific quantitative goals and reported device performance against those goals for the K200893 device. Instead, it compares the technological characteristics and performance of the subject device to the predicate in a qualitative manner and mentions general ISO and ASTM standards to which the device was tested.
The closest information relating to performance criteria and reported performance is about Volume Accuracy and Minimum Flow Rate, which are compared to the predicate device.
Here's an attempt to create the requested table based on the limited quantitative performance data provided, and then address the other points.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, explicit "acceptance criteria" with pass/fail thresholds are not clearly stated for the K200893 device. Instead, the document compares its performance characteristics to the predicate device. The information below is extracted from the "Comparison of Technological Characteristics with The Predicate Device" table and the "Differences Compared to Predicate Device / Substantial Equivalence Discussion" section.
| Performance Characteristic | Acceptance Criteria (from predicate/discussion, if explicit) | Reported Device Performance (ProntoPump Sterile Tube Set K200893) |
|---|---|---|
| Volume Accuracy | Predicate: +/- 0.02 mL (0.2-2.0 mL), +/- 1% (>2.0 mL) | New Device: +/- 5% (1.0-5.0 mL), +/- 4% (>5 mL) |
| Minimum Flow Rate at Top Speed | Predicate: At least 11 mL /s | New Device: At least 21 mL /s |
| Tube Set Maximum Usage | Predicate: Labelled for 200 L maximum use | New Device: Labelled for 40 L maximum use |
| Sterilization Assurance Level (SAL) | Sterilized by Gamma radiation (10^-6) (Implied standard) | Sterilized by Gamma radiation (10^-6) |
| Biocompatibility | ISO 10993-1:2018 | Compliant with ISO 10993-1:2018 |
| Packaging Integrity | ISO 11607-1 & ISO 11607-2 | Compliant with ISO 11607-1, ISO 11607-2 |
| Particulate Matter | USP 788 | Compliant with USP 788 |
| General Infusion Equipment Standards | ISO 8536-4:2019 | Compliant with ISO 8536-4:2019 |
| Small-bore Connectors Standards | ISO 80369-7:2016 | Compliant with ISO 80369-7:2016 |
| Shipping Performance | ASTM D4169-16 | Compliant with ASTM D4169-16 |
Note: The document states "Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container is substantially equivalent in terms of safety and effectiveness." This indicates that the "reported device performance" for volume accuracy, while different, was deemed acceptable for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The document refers to "Bench Testing" against various ISO and ASTM standards. However, it does not provide any specific sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing results, as these are laboratory/bench tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
N/A - This submission is for a medical device (sterile tube set) and relies on bench testing against established engineering and safety standards (ISO, ASTM, USP). There are no human experts involved in establishing a "ground truth" in the context of clinical interpretation or diagnostic accuracy for this type of device. The ground truth is defined by the objective metrics and criteria outlined in the referenced standards.
4. Adjudication Method for the Test Set
N/A - As this is bench testing against objective engineering and safety standards, no adjudication method (like 2+1, 3+1 consensus) is applicable or mentioned. The results are typically measured against the specified tolerances within the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A - This document describes a syringe pump accessory (sterile tube set), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A - This device is a physical medical device (tube set) used in conjunction with a pump, not an algorithm. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by the requirements and specifications within recognized international standards for medical devices, particularly those related to infusion equipment, sterilization, packaging, and biocompatibility. These include:
- ISO 8536-4:2019 (Infusion equipment)
- ASTM D4169-16 (Shipping Containers)
- ISO 80369-7:2016 (Small-bore connectors)
- ISO 10993-1:2018 (Biocompatibility)
- USP 788 (Particulate Matter)
- ISO 11607-1:2019 & ISO 11607-2:2019 (Packaging)
- ISO 11137-1:2006 & ISO 11137-2:2013 (Radiation Sterilization)
- The established performance characteristics of the legally marketed predicate device (K062909) also serve as a comparative ground truth for evaluating substantial equivalence.
8. The Sample Size for the Training Set
N/A - This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" for this submission.
9. How the Ground Truth for the Training Set Was Established
N/A - As there is no training set for a physical device, this question is not applicable.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.